Top Regulatory News Stories – Week Ending August 9, 2019

Daiichi Sankyo announced that the US FDA approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.  https://www.prnewswire.com/news-releases/fda-approves-daiichi-sankyos-turalio-pexidartinib-for-the-treatment-of-select-patients-with-tgct-a-rare-and-debilitating-tumor-300895924.html

Last week the FDA approved Bayer’s Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer. https://www.prnewswire.com/news-releases/fda-approves-bayers-nubeqa-darolutamide-a-new-treatment-for-men-with-non-metastatic-castration-resistant-prostate-cancer-300893680.html

Stoke Therapeutics announced that the FDA has granted orphan drug designation to its lead product candidate, STK-001, an investigational new treatment for Dravet syndrome.  http://www.firstwordpharma.com/node/1657206#axzz5vvIFZYh6

Alnylam Pharmaceuticals announced that the FDA has accepted their NDA and granted Priority Review status for givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) in development for the treatment of acute hepatic porphyria (AHP) https://www.businesswire.com/news/home/20190805005489/en/Alnylam-Announces-U.S.-Food-Drug-Administration-FDA/

Nektar Therapeutics and Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb’s Opdivo®(nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.  https://www.drugs.com/clinical_trials/nektar-therapeutics-bristol-myers-squibb-announce-u-s-fda-breakthrough-therapy-designation-18227.html

The FDA’s Antimicrobial Drugs Advisory Committee backed Gilead’s move to expand Descovy label — but stopped short of endorsing broad PrEP use.  https://endpts.com/fda-adcom-backs-gileads-move-to-expand-descovy-label-but-stops-short-of-endorsing-broad-prep-use/

Amarin Corporation announced that the FDA plans to hold an advisory committee meeting, tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa® (icosapent ethyl) labeling based on the REDUCE-IT™ cardiovascular outcomes study.  https://www.globenewswire.com/news-release/2019/08/08/1899639/0/en/Amarin-Announces-FDA-Notification-of-Advisory-Committee-Meeting-Planned-to-be-Held-in-November-2019-in-Connection-With-Vascepa-REDUCE-IT-sNDA.html

The FDA said Novartis submitted a drug application with manipulated data and didn’t inform regulators of the issue until one month after approval. DA said Novartis submitted a drug application with manipulated data and didn’t inform regulators of the issue until one month after approval. https://www.fiercepharma.com/pharma/fda-weighs-civil-and-criminal-penalties-over-manipulated-data-novartis-zolgensma-application?mkt

In other news…

Aquinox Pharmaceuticals and Neoleukin Therapeutics announced that the two companies entered into a definitive merger agreement under which Aquinox agreed to the acquisition of Neoleukin. https://www.globenewswire.com/news-release/2019/08/06/1897411/0/en/Aquinox-Pharmaceuticals-and-Neoleukin-Therapeutics-announce-merger-agreement.html

South San Francisco-based RAPT Therapeutics announced it is postponing its initial public offering (IPO) it filed earlier to raise $86 million. No reasons were given for the postponement. https://www.biospace.com/article/rapt-therapeutics-postpones-86-million-ipo/?utm

Bayer has announced it is acquiring BlueRock Therapeutics. Bayer was part of the 2016 joint venture with Versant Ventures to found BlueRock, which was launched with a $225 million Series A financing round. https://www.biospace.com/article/bayer-buys-bluerock-therapeutics-for-600-million/?utm

This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/

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